Arrhythmia Identification in Syncope Patients: ePatch® Versus 24h Holter

Not Applicable

Recruiting

• Conditions: Arrythmia; Syncope
• Interventions: Device: ePatch ® Extended Wear Holter (EWH)

• Registration Number: NCT06310707
• Lead Sponsor: Philips Clinical & Medical Affairs Global

Brief Summary

This study is a Multi-center, prospective, randomized, unblinded, two-arm study to assess if 7-days of cardiac monitoring using the ePatch Holter results in identification of more clinically actionable arrythmia for patients with symptoms of syncope than standard 24 hour Holter monitoring.

Detailed Description

This study is a multi-center, prospective, randomized, unblinded, two-arm study to assess if 7-days of cardiac monitoring using the ePatch Holter results in identification of more clinically actionable arrythmia for patients with symptoms of syncope than standard 24 hour Holter monitoring. Approximately 256 adult subjects with symptoms of syncope will be randomized 1:1 to wear either the Philips ePatch Extended Wear Holter (7 day) or Standard Wear Holter (24 hours). Randomization will be balanced for gender.

Study Timeline

• Study Start: 2023-11-09
• Study First Submitted: 2023-11-29
• Status Verified: 2024-03
• Study First Submitted QC: 2024-03-06
• Last Update Submitted: 2024-03-06
• Study First Posted: 2024-03-15
• Last Update Posted: 2024-03-15
• Primary Completion: 2025-04
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 128

Inclusion Criteria

1. Age ≥ 18 years old
2. Recommended for ambulatory cardiac Holter monitoring due to symptoms of syncope
3. Able to comply with continuous ECG monitoring for up to 7 days
4. Able and willing to replace the Patch electrode at home
5. Capable of providing voluntary informed consent and mentally and physically willing and able to be compliant with the protocol, including the follow-up visit(s)

Exclusion Criteria

1. Patient with chronic Atrial Fibrillation (AF)
2. Patient with implanted pacemaker/defibrillator
3. Patient with known allergy to adhesive materials and/or hydrogel
4. Patient with broken, damaged, or irritated skin where ECG patch will be placed

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ePatch® Extended Wear Holter (EWH) Arm	ePatch ® Extended Wear Holter (EWH)	Participants will undergo long-term continuous ambulatory ECG recording of 7-day duration

Primary Outcome Measures

Name	Time	Method
Diagnostic yield (frequency) of clinically actionable arrythmia	Up to 7 days	In patients indicated for cardiac monitoring due to syncope, show that the diagnostic yield (frequency) of clinically actionable arrythmia with 7 days of monitoring using the ePatch Extended Wear Holter is superior to what would be seen with the Standard Wear Holter (24 hours).

Secondary Outcome Measures

Name	Time	Method
Cost related to cardiac monitoring	Up to 7 days	- Compare clinical workflow costs from 7 days of cardiac monitoring using the ePatch Extended Wear Holter vs. 24 hours of cardiac monitoring with Standard Wear Holter.
Occurrence of symptomatic events	Up to 7 days	Occurrence of symptomatic events in 7 days of monitoring using the ePatch Extended Wear Holter vs. Standard Wear Holter (24 hours).
Patient Quality of Life as measured by Patient Experience Survey	Up to 7 days	Patient Quality of Life will be measured using survey data at 24-hours (Standard Wear Holter and ePatch) and at end of service (7 days for ePatch arm); Each question in the Patient Experience Survey has 5 levels: no problems (1), slight problems (2), moderate problems (3), severe problems (4) and extreme problems (5). Higher scores mean a worse outcome.
Number of Atrial Fibrillation (AF) diagnoses > 30 seconds	Up to 7 days	Number of Atrial Fibrillation (AF) diagnoses \> 30 seconds with 7 days of monitoring using the ePatch Extended Wear Holter vs. Standard Wear Holter (24 hours).
Patient Quality of Life as measured by EQ-5D-5L	Up to 7 days	Patient Quality of Life will be measured using the EQ-5D-5L at 24-hours (Standard Wear Holter and ePatch) and at end of service (ePatch arm only, at 7 days). The EQ-5D-5L stands for EuroQol, 5 dimensions, 5 levels.; EQ-5D-5L comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems (1), slight problems (2), moderate problems (3), severe problems (4) and extreme problems (5). Higher scores mean a worse outcome.
Number of Clinically actionable arrhythmia	Up to 7 days	Clinically actionable arrhythmia yield vs days of data collected; * Analysis for all patients; * Analysis for patients with sporadic symptoms (less than one per day)
Time Holter is worn/ removed	Up to 7 days	Compare time Holter is worn/removed; - Assess via diary

Trial Locations

Locations (2)

Hospices Civils de Lyon - Hôpital Cardiologique Louis Pradel; 🇫🇷 Bron, France

Deutsches Herzzentrum der Charité (DHZC) - Campus Benjamin Franklin; 🇩🇪 Berlin, Germany